Williams College operates a Human Research Protection Program to protect the rights and welfare of individuals who volunteer to participate in research. While the ultimate responsibility for the treatment of all human participants in research rests with the individual researcher (faculty, students, or staff) who has been given the privilege to conduct research with humans, the Institutional Review Boards exist as a safeguard to promote the ethical and responsible treatment of human participants in research.
College policy requires that all research that involves human participants, regardless of the source of financial support, must be reviewed and approved by the Institutional Review Board (IRB) before it can be initiated. Guiding this review process by the IRB is the application of federal and state laws and various ethical principles, particularly those articulated in the Belmont Report: (1) Respect for Persons, (2) Beneficence, and (3) Justice.
How long does IRB approval last?
The approval period for research is usually one year. Federal regulations require that the IRB conduct a continuing review of human subject research at least once per year. Subject recruitment, data collection, or data analysis without continuing IRB approval is prohibited past the expiration date assigned by the IRB. See forms for modifications, continuing review, and closure of research protocols.
Application Deadline and Schedule for Meetings
All IRB members must complete the assurance training at: http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp and certify to the IRB chair that they have done so.
Principal investigators, project staff conducting the informed consent process, and all others engaged in human subjects research must complete the web-based training at: http://phrp.nihtraining.com/users/login.php. Proof of completion of such training must be provided in writing to the IRB committee before any work on the project commences. In addition to this initial certification, recertification is required every three years.
Other possible websites:
• University of Wisconsin-Madison Human Subjects Tutorial
• University of Virginia Research Training for Social/Behavioral Research
http://irb.virginia.edu/ (click on SBS Training)
• Membership on the IRB shall meet the guidelines defined by the Code of Federal Regulations (CFR). The IRB must have at least 5 members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds (including considerations of their racial cultural heritage and their sensitivity to issues such as community attitudes), to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
• The IRB must include one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are non-scientific. In addition, the IRB must include a person knowledgeable in institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB must include a least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. The IRB shall consider the type of community from which the institution will draw its research subjects. A representative from that type of community, including minorities shall be considered in the IRB membership.
Federal and state regulations mandate that research involving human participants must be reviewed and approved by an Institutional Review Board (IRB) provided for in its assurance filed with the Office of Human Research Protections and will be subject to continuing review by the IRB. The IRB is responsible for providing guidance and oversight for the human participant protection program and for helping to maintain compliance with applicable laws, regulations, and policies. The IRB is responsible for the following oversight functions:
1. Determine what activities constitute human participant research.
2. Review, approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy prior to the commencement of the research.
3. Require that information given to participants as part of informed consent is in accordance with appropriate laws, regulations, and international standards. The IRB may require that additional information be given to the participants when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
4. Require documentation of informed consent or waive documentation in accordance with federal and New York State laws and regulations. When research activities are being proposed to be conducted in other states and/or countries by Cornell faculty, staff, and/or students, the research activities will be approved in compliance with the regulations for those specific research locations.
5. Notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
6. Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, (unless the research has been classified as "Exempt") and have authority to observe or have a third party observe the consent process and the research.
7. Suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional official and the department or agency head.
IRB Minutes and Documentation: Minutes and documentation of all other IRB meetings and protocol reviews will be provided to the Provost. The minutes of IRB meetings will include the separate deliberations, actions, and votes for each protocol undergoing preliminary or continuing review, as well as the vote on all IRB actions including the number of members voting for, against, and abstaining. The minutes should reflect IRB determinations regarding risk and approval period (review interval). For research undergoing an expedited review, these findings should be documented by the IRB Chair and communicated to all IRB members for inclusion in the IRB minutes.
IRB: All protocols and descriptions of relevant IRB actions are to be retained by the chair of the IRB for three years after the expiration of the protocol’s approval (expiration date is one year after the committee’s action – the protocol expires if renewal is not sought by the expiration date).
Investigator: Retain for three years beyond the date of completion of the research or project all protocols, copies of correspondence with the IRB, informed consent forms, progress reports, reports of injuries to participants, and other correspondence related to the use of human participants.
When does a class assignment require IRB approval?
Student class assignments include those conducted during or outside of class with students enrolled in an official course (for credit or not for credit), as well as activities in fulfillment of class assignments involving interactions with individuals other than the members of the class. These assignments are typically initiated and completed within a single term. Faculty members may design assignments that engage students in interaction with individuals or data about individuals to teach research methods or to help students understand concepts covered by the course.
Student class assignments, as a general rule, are not systematic data collection efforts intended to develop or contribute to generalizable knowledge and, thus, do not meet the federal regulatory definition of " research." Therefore, as a rule, student class assignments do not fall under the jurisdiction of the IRB and do not require IRB application, approval, or oversight. For the most part, they are not intended to create new knowledge or to lead to scholarly publication or dissemination.
If instructors do wish to use such assignments for scholarly presentation or publication, however, they must submit the proposed study to the IRB for review and wait until approval before engaging students in the assignment.
Even when a class assignment is "non-research" and, thus, not under the jurisdiction of the IRB, faculty members have an affirmative obligation to ensure that students understand their ethical obligations in carrying out their assignments. Instructors should provide guidance to students collecting information so as to minimize any unwitting or unintentional harms to other students or to individuals, especially if students will interact with or collect private information about vulnerable individuals.
Although most student class assignments pose little or no risk to students or others, some may warrant enhanced attention because of risks to students or to the individuals outside the class. These risks may include physical harm or potential psychological, social, economic, or legal harm, especially when data is collected about sexual activity, use of alcohol or illegal drugs, or involvement in illegal activities. Such risks can be exacerbated when the individuals outside the classroom are minors, pregnant women, prisoners, or people who are otherwise vulnerable, such as cognitively impaired persons. When instructors assign students to collect information about these vulnerable groups, they should take special care to ensure that students realize the potential for harm and take all possible steps to eliminate the risks to these individuals.
NOTE: This policy applies to student class assignments only. Those independent research projects conducted by students, such as theses, honors projects, and independent study projects, that collect data through interactions with living people or access to private information do fall under the jurisdiction of the IRB. Application to the IRB for these student research projects must include an endorsement and acceptance of overall responsibility by a faculty member.